Treatment of ITP With Rituximab and / or Accutane

Sponsor
Peking University People's Hospital
Study ID
NCT02757196
Phase
PHASE2
Status
Unknown

Conditions

  • Immune Thrombocytopenia

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab plus methylprednisolone — DRUG
    rituximab （1000mg IV day1, week 3, week 17 , and week 19）
  • methylprednisolone — DRUG
    1mg/kg, oral or IV; begin to reduce at week 4, reduce 8mg every 2 weeks, then another 8 weeks later reduce 2-4mg every 2-4 weeks

Study Details

a prospective, multicenter, randomized, open-label, Phase II, two arms interventional trial performed in 5 departments of hematology in China

Key Dates

Start date
May 31, 2016
Status verified
May 2016
Primary completion
Dec 31, 2017
Completion
Dec 31, 2018

Study Design

Enrollment
112 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab plus methylprednisolone
    Combination therapy with rituximab （1000mg IV day1, week 3, week 17 , and week 19）plus short-term methylprednisolone (1mg/kg, oral or IV; reduce to 50% of base dose at week 4, then reduce 8mg every 1 week until stopped).
  • Active Comparator: Methylprednisolone
    standard dose methylprednisolone alone (1mg/kg, oral or IV; begin to reduce at week 4, reduce 8mg every 2 weeks, then another 8 weeks later reduce 2-4mg every 2-4 weeks).

Primary Outcome Measure

Relapse free survival [ Time Frame: From date of randomization until the date of relapse or death from any cause, whichever came first, assessed up to 1 year ]

Central Contacts

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